1. Field Of The Invention
This invention relates to urinary devices and, more particularly, to an external urinary collection device for use by females.
2. Background Art
The number of women who are incontinent of urine is enormous. There are several physiologic bases for such urinary incontinence, with many principal and overlapping causes. The bladder may be spastic and void small amounts of urine on a frequent basis. Loss of pelvic muscle tone may result in stress incontinence where the bladder is fully or partially emptied during any activity that results in increased intra-abdominal pressure (e.g., coughing, sneezing, laughing, standing). More importantly, a patient may have lost cognitive functioning or physical control from medication, surgical complications, mental disorders, or the like and may have no effective bladder control. Patients confined to a bed can also be considered as incontinent and in need of assistance with urine control. Current methods of dealing with this major problem of urinary incontinence are inadequate.
Because no prior external urine collection device has proven satisfactory, only two means are currently available and regularly used for addressing the problem of female incontinence. Women are either diapered, with the attendant indignity, and odor and risk of skin breakdown for practical lack of frequent changing, or they are chronically catheterized with an indwelling bladder tube. While bladder catheterization usually maintains dryness and is convenient for patient caretakers, it also virtually guarantees infection. Even when introduced aseptically, the bladder's defenses against infection are breached. Bacteria on the external genito-urinary area use the catheter surface to ascend into the bladder, where they rapidly multiply in an ideal environment for growth. Urinary tract infections of the bladder and kidneys, with spreading thence into the blood stream, are a common occurrence for internally catheterized patients and are a particular problem in patients catheterized for periods longer than forty-eight hours.
There has been a recognized need for quite some time for a practical, effective and safe external catheter or urine collection device for females. U.S. Pat. No. 4,822,347 discloses a urine collection device that is adhesively attached to the skin of the wearer in the region immediately surrounding the urethral orifice. However, this device is relatively uncomfortable for a patient and cannot remain in place for extended periods of time without causing skin discomfort or trauma. A number of other external female catheters have been suggested in the prior art as shown in U.S. Pat. Nos. 3,194,238; 4,484,917; 4,496,355; 4,568,339; 4,631,061; 4,713,065; 4,747,166; 4,813,943; 4,846,817; 4,936,838; and U.S. Pat. No. 5,053,027. These devices have a number of problems which render all of them ineffective for use on a practical basis. Most of these devices are molded into particular configurations and are not readily adapted for use by a wide range of females having varying physical characteristics, sizes and the like. In addition, several of these devices must be placed within the labial lips of a patient, causing discomfort and embarrassment. Basically, the prior external female catheters are not practical for extended use on a wide range of female patients.
It is, therefore, an object of the present invention to provide an effective and comfortable means of urine collection for women who are either incontinent of bladder or who are incapacitated and cannot use a toilet. It is a further object to provide such a urine collection device which can result in a custom fit on an individualized basis for various female patients. It is yet a further object to provide a urine collection device which has maximum efficacy and enhanced safety.